Drug Distribution and Storage

Flashcards covering the supply chain, WHO guidelines for pharmaceutical distribution and storage, vehicle and equipment requirements, and specific storage temperature limits.

WHO Practice Guideline Objective

To ensure the quality and identity of pharmaceutical products during the entire distribution process and avoid the introduction of counterfeit products into the marketplace.

Organization and Management (Infrastructure)

The entity must determine, provide, and maintain the infrastructure and work environment needed to achieve conformity to product requirements, including a clear organizational chart.

Designated Person

An individual appointed within the organization with defined authority and responsibility for ensuring a quality system is implemented and maintained.

Quality System and Traceability

Includes periodic risk assessments, use of authorized procurement/release procedures from approved suppliers, and a suitable internationally compatible product coding identification system.

Quarantine Status

The temporary storage area used for the segregation of suspected or recalled products until a final decision on their status is made.

FEFO

First expire/first out; a stock management system ensuring products with the earliest expiration dates are distributed first.

Special Risk Storage Materials

Items such as radioactive materials, narcotics, hazardous substances, and pressurized gases that require dedicated areas with additional safety and security measures.

Stock Reconciliation

A periodic process of comparing actual physical stock against recorded data to ensure accuracy.

Vehicle Capacity and Equipment

Vehicles must be appropriately equipped and of sufficient capacity to prevent contamination, maintain stability, and allow effective cleaning.

GPS/Electronic Tracking

Technology used when feasible to enhance the security of pharmaceutical products while in transit in a vehicle.

Shipment Container Labeling

Must include container content, handling and storage conditions, and the name and address of the manufacturer.

First out/last in

The systematic method used for loading vehicles and containers during the dispatch process.

Documentation Standards

Written instructions and records documenting all activities related to storage and distribution that are clear, orderly, and retained with safeguard facilities (both soft and hard copies).

Repackaging and Relabeling

Activities that are generally not allowed unless specifically authorized by the concerned entity.

Recall Process Final Report

A document issued at the end of a recall that includes reconciliation between the delivered and recovered quantities of pharmaceutical products.

Contract Activity

Any distribution activity delegated to another person or entity must be authorized and governed by a written contract defining responsibilities and training requirements.

Going Green

A systematic approach to warehouse environmental management involving digitalization to save paper, energy saving, waste management, and recycling programs.

Alphabetical System

A simple consistent method used in community pharmacies for easy stocking and retrieval of products by all staff members.

Soft Pharma

A type of software program that can facilitate the identification of short-dated products intended for removal from active inventory in a pharmacy.

Controlled room temperature

Storage recommended limits of $15$ to $25 \, ^{\circ}C$.

Cold or cool place

Storage recommended limits of $8$ to $15 \, ^{\circ}C$.

Store in a refrigerator

Storage recommended limits of $5 \pm 3 \, ^{\circ}C$. (Also referred to as Chilled).

Store in a freezer

Storage recommended limits of $-20 \pm 5 \, ^{\circ}C$.

Store in deep freezer

Storage recommended limits of $-70 \pm 10 \, ^{\circ}C$.

Store in a dry place / Protect from moisture

Storage conditions requiring no more than $60 \%$ relative humidity.

Store under ambient conditions

Store in well-ventilated premises at temperatures between $15 \, ^{\circ}C$ and $30 \, ^{\circ}C$ and no more than $60 \%$ relative humidity.